Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Cerebral Palsy
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Safety (adverse events)
Study Overview
Brief Summary
This trial will study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells for the treatment of Cerebral Palsy
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Cerebral Palsy
Exclusion Criteria
- •Active infection
- •Active cancer
- •Chronic multisystem organ failure
- •Pregnancy
- •Clinically significant Abnormalities on pre-treatment laboratory evaluation
- •Medical condition that would (based on the opinion of the investigator) compromise patient's safety
- •Previous organ transplant
- •Seizure disorder
- •Hypersensitivity to sulfur
Arms & Interventions
Treatment Group
Single intravenous infusion of 100 million cells
Intervention: autologous adipose derived mesenchymal stem cells (Biological)
Outcomes
Primary Outcomes
Safety (adverse events)
Time Frame: Four year follow-up
Clinical monitoring of possible adverse events or complications
Secondary Outcomes
- Efficacy: Gross Motor Function Measure (GMFM)(Four year follow-up)